MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO2 REGULATION UNIT

Model Number UCR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abdominal Distention (2601)

Event Date 04/22/2021

Event Type  Injury  

Event Description

It is reported after a diagnostic colonoscopy using an endoscopic co2 regulation unit with a cf hq190l colonoscope, the patient had abdominal pain and distention (abdomen tight and tender) thought to be due to hyper-inflation.The patient required unplanned labs, computerized tomography (ct) exam and surgical consult due to these symptoms.Two hours and 15 minutes after initial distention was noted by the physician, the patient¿s pain and distention resolved, ct showed no bowel perforation.The patient discharged home with driver same day.The endoscopic co2 regulation unit was tested per usual guidelines (immersed in water, no air bubbles emitted, then tested with finger lightly covering air/water button, bubbles emitted, then button fully depressed and water squirting out the side channel), everything checked out okay, nothing seemed abnormal.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11829585
• MDR Text Key: 250829044
• Report Number: 2951238-2021-00337
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2021,05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UCR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 86